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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05429281
Other study ID # RHPT/0021/0114
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 7, 2021
Est. completion date April 28, 2022

Study information

Verified date June 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was conducted to compare the effect of Pilates-based core strengthening (PsCS) and plyometric-based muscle loading (PlyoML) and their combination on postural control, balance, and mobility in children with unilateral cerebral palsy (ULCP). Eighty-one children with ULCP were randomly allocated to the PsCS (n = 27), PlyoML (n = 27), or combined intervention (n = 27) group. Participants in the three groups were assessed for postural control, balance, and mobility on the pre and post-treatment occasions.


Description:

Eighty-one children with ULCP were recruited from the Physical Therapy Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 12 and 18 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity levels 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, had attentional neglect, and if they had cardiopulmonary problems preventing them from performing high-intense exercise training. Outcome measures - Postural control: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system. - Balance and mobility: The Community Balance and Mobility Scale (CB&M), Functional Walking Test (FWT), and Timed Up and Down Stair test (TUDS) were used to quantify balance and mobility capacity. Interventions All groups were trained for 45 minutes, twice per week, for 12 successive weeks. The PsCS group performed eight Pilates exercises geared predominantly toward the core muscles. The PlyoML group performed 10 plyometric exercises primarily focused predominantly on the lower body. The combined group combined the same exercises as the PsCS and PlyoML groups, although with half the number of sets/repetitions.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date April 28, 2022
Est. primary completion date April 28, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - Unilateral cerebral palsy - Age 12-18 years - Motor function level I or II according to the Gross Motor Function Classification System. - Spasticity level 1 or 1+ according to the Modified Ashworth Scale Exclusion Criteria: - Structural deformities/contractures - Musculoskeletal or neural surgery in the last year - BOTOX injection in the last 6 months. - Cardiopulmonary disorders interfere with the ability to engage in exercise training. - Perceptual and/or behavioral disorders.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pilates-based Core Strengthening Exercises
The PsCS group performed eight Pilates exercises over 45 minutes, three times per week for 12 successive weeks. The training was conducted under the supervision of a physical therapist who had more than 5 years of experience in Pilates.
Plyometric-based Muscle Loading Exercises
The PlyoML group performed 10 plyometric exercises over 45 minutes, three times per week for 12 successive weeks. The training was conducted under the close supervision of a licensed pediatric physical therapist. The safety and performance guidelines, defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association, were considered during training.
Combined Pilates and Plyometrics
The combined training group performed the same exercises as the PsCS and PlyoML groups, although with half the number of sets/repetitions over 45 minutes, three times per week for 12 successive weeks. The PsCS and PlyoML were executed within the same session, with a 10-to-15-minute rest interval. The training was conducted under the close supervision of a licensed pediatric physical therapist. The safety and performance guidelines, defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association, were considered during training.

Locations

Country Name City State
Saudi Arabia Ragab K. Elnaggar Al Kharj Riyadh

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Limit of postural stability The capacity to control and move the center of gravity in various directions across their base of support was assessed utilizing the Biodex balance system. Values are expressed as accuracy % and higher scores mean better balance capability. 2 months
Secondary Community Balance and Mobility Scale Community Balance and Mobility Scale is a performance-based measure assessing high-level balance capabilities while also addressing the speed and coordination components necessary for the ordinary community function.
The scale consists of 13 items. Item scores range from zero (complete inability of task execution) to five (the most successful task completion), and the maximum possible score is 96. A higher score indicates better performance.
2 months
Secondary Functional Walking Test The Functional Walking Test is a valid and reliable measure for assessing functional waking capacity in ambulant children with cerebral palsy. The test consists of 11 items including kneel walking, transitions to standing, incline walking, ascending/descending stairs, and walking a narrow beam, all of which focus on the postural control and balance components of walking. The maximum score is 23 and higher scores indicate better walking capacity 2 months
Secondary Timed Up and Down Stair test The Timed Up and Down Stairs test measures the time (in seconds) that the children take to go up a 14-step stair flight (each step was 20 cm in height), turn around, and come back down. Shorter time indicates better performance. 2 months
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